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The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device's kit includes a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

The provided text describes the Minuteful-kidney test (K222921) and its substantial equivalence to a predicate device (K210069). However, it specifically states that "The rest of the analytical performance studies are still relevant for the modified version of the Minuteful - kidney test, and their summary is available in the predicate device documentation (K210069)." This means the detailed acceptance criteria and the comprehensive study demonstrating the device meets those criteria are not present in this document but are referenced as being in the predicate device's documentation.

Therefore, I can report on the studies performed for K222921 to assert its substantial equivalence, but I cannot provide a table of acceptance criteria and reported device performance from this document for the overall device functionality as those details are in K210069. Nor can I provide information regarding sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for K222921's overall performance since those are tied to the K210069 submission.

The studies described in K222921 (the current device) are focused on demonstrating that changes made to the device in K222921 do not negatively impact performance, thus maintaining substantial equivalence to its predicate.

Here's an analysis based solely on the provided text for K222921, noting the limitations:

Acceptance Criteria and Device Performance (Limited to K222921 changes):

Since the comprehensive performance data is referenced in K210069, the "acceptance criteria" discussed here are implicitly related to demonstrating that the modifications in K222921 (e.g., multilingual support, software enhancements) do not degrade the performance previously established for K210069. The studies conducted for K222921 focused on the robustness of the Image Validation Transfer System (IVTS) and the analytical limits of detection.

Study Details (for K222921 specific enhancements):

1. Sample size used for the test set and the data provenance:

   • Limit of Detection (LoD): The document does not specify the sample size for the LoD study for K222921. It mentions the study was designed and executed according to CLSI document EP17-A2.
   • Illumination, Physical, Shadow, Blurriness, Misplaced Urine Stick, Dirty Color-Board Studies: The document refers to "Tested smartphones" and "different conditions," but specific numerical sample sizes (e.g., number of images, tests, or smartphones) are not provided. The data provenance is implied to be laboratory-controlled since these are experimental conditions, but no explicit country of origin or retrospective/prospective nature is stated for these new studies. The overall device is intended for home use, so these validations mimic adverse home conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the K222921 document. These types of analytical studies typically rely on reference methods or scientifically established standards rather than expert consensus. For the clinical performance, the document refers to the predicate device K210069, where such details would likely be found if applicable.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided for these specific analytical studies. The assessment of whether performance was "not impacted" would likely come from statistical analysis against pre-defined thresholds.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC or comparative effectiveness study involving human readers with and without AI assistance is mentioned in the K222921 submission. This device is an in-vitro diagnostic home-use test system where the smartphone app performs the measurement, rather than assisting a human in interpreting diagnostic images. Thus, the concept of "human readers improve with AI" in a traditional MRMC sense does not directly apply to this device's function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The core of the described studies (LoD, Illumination, Physical, Shadow, Blurriness, Misplaced Urine Stick, Dirty Color-Board) are indeed standalone performance tests of the device's algorithmic capability to accurately read the test strip under various challenging conditions encountered in a home setting. The device is described as having "image recognition algorithms" and performing "image analysis activities."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the analytical studies described (LoD, Illumination, etc.), the ground truth would be based on controlled experimental conditions and potentially quantitative reference measurements (e.g., known concentrations for LoD, controlled lighting conditions). The document does not specify the exact methods for establishing this ground truth but implies scientific rigor (e.g., "in accordance with guidance provided by the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2"). For the clinical performance aspects, the document refers to K210069.

7. The sample size for the training set:

   • Not provided in the K222921 document. Training set details would typically be part of the initial K210069 submission for the machine learning algorithms.

8. How the ground truth for the training set was established:

   • Not provided in the K222921 document. This information would be found in the K210069 submission, likely involving laboratory-controlled tests with known analyte concentrations and reference methods for accurate measurement.

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The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

Here's a breakdown of the acceptance criteria and study information for the Healthy.io Minuteful - kidney test (K210069), based on the provided document:

Acceptance Criteria and Device Performance for Minuteful - kidney test (K210069)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria by reporting performance results against the predicate device that demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: More than 450 subjects were recruited for the clinical trials.
• Data Provenance: The document does not explicitly state the country of origin. The study was a prospective clinical trial, as subjects were "recruited" and tasks were "completed" within the context of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth was established by comparing the Minuteful - kidney test results to those obtained from a professional user performing the test on the URISCAN Optima Urine Analyzer (predicate device).

• Number of Experts: Not explicitly stated as a count of individual professionals, but referred to as "a professional user." It's implied that this
  professional operated the predicate device.
• Qualifications: "Professional user" suggests trained laboratory or healthcare personnel familiar with operating the URISCAN Optima Urine Analyzer and interpreting its results. Specific credentials (e.g., medical technologist, clinical laboratory scientist, years of experience) are not provided.

4. Adjudication Method for the Test Set

The adjudication method involved a 2-part comparison:

1. A lay user (subject in the clinical trial) performed the test using the Minuteful - kidney test app.
2. A professional user (operating the predicate device, URISCAN Optima Urine Analyzer) then performed the test on the same urine sample.

The professional user was blinded to the results of the lay user until after they had completed their test. This can be considered a form of adjudication where the predicate device's result, as read by a professional, serves as the comparison benchmark. There was no explicit multi-expert consensus or 2+1/3+1 method described for establishing a single "ground truth" independent of the comparison devices; rather, the predicate device's output was the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly done in the sense of comparing multiple human readers with and without AI assistance on the same cases. The study compared a lay user with the AI-powered device to a professional user with a predicate device. It was a method comparison study to show substantial equivalence, not a study evaluating human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The clinical performance study involved a lay user interacting with the smartphone application and performing the test steps guided by the app. While the app uses "image recognition algorithms" and "machine learning algorithmic components," it is not a purely standalone algorithm-only performance assessment in the sense of a laboratory-based algorithm evaluation without human interaction for image capture and strip preparation. However, the analytical performance testing (Precision, Interference, Limit of Detection, Linearity, Stability) would represent the closest to "standalone" algorithm performance testing, as these evaluate the device's technical capabilities in a controlled environment. The linearity study, showing 100% exact match for every level of albumin, creatinine, and ACR, is a strong indicator of the core algorithm's accuracy at different concentrations.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device (URISCAN Optima Urine Analyzer) operated by a professional user. This is a form of reference standard comparison where the predicate device's output serves as the truth.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set used for the device's algorithms.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth was established for the training set of the device's algorithms. It only describes the ground truth for the clinical performance (test set) comparison.

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The Mission Urinalysis Reagent strips (Microalbumin/Creatinine) are intended for the semi quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer. These measurements are used to assist diagnosis for kidney function. It is intended for professional use only at point-of-care locations.

The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are firm plastic strips that contain two reagent areas to test for Microalbumin (low concentration of albumin) and creatinine in urine. Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) can be read by the Mission® U120 Urine Analyzer.

The provided document describes the clinical performance and acceptance criteria for the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) device. This device is intended for the semi-quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer, to assist in diagnosing kidney function.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document compares the new device against a predicate device (CLINITEK Microalbumin Reagent Strips) to establish substantial equivalence. The primary performance metric presented is agreement in classifying Albumin-to-Creatinine (A:C) ratios.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 390 urine specimens.
• Data Provenance: Retrospective, collected randomly at three clinical sites from patients. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in San Diego, CA, suggesting U.S. clinical sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The "ground truth" for the test set was established by comparing the results of the new device (Mission® Urinalysis Reagent Strips read by Mission U120 Urine Analyzer) to the predicate device (CLINITEK Microalbumin Reagent Strips read by Clinitek Status Analyzer). No independent human experts were stated to have established a separate ground truth for the clinical accuracy study. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set:

No explicit adjudication method (like 2+1 or 3+1) is mentioned. The study directly compares the results of the new device against the predicate device for each specimen.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is an in-vitro diagnostic (IVD) test strip read by an analyzer, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, the performance study is a standalone evaluation of the device system (reagent strips + analyzer). The device itself performs the semi-quantitative measurement. While human operators are involved in dipping the strips and initiating the reading, the "performance" described is that of the automated analytical system in interpreting the strip's reaction.

7. The Type of Ground Truth Used:

The ground truth for the clinical accuracy study was the results obtained from a legally marketed predicate device (CLINITEK Microalbumin Reagent Strips read by Clinitek Status Analyzer). This is a common approach for demonstrating substantial equivalence for new IVD devices.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning or AI. For a traditional IVD device like this, the development and calibration of the reagent strips and analyzer would involve extensive internal testing and optimization, but it's not typically referred to as a "training set" in the same way as for AI algorithms. The clinical accuracy study used 390 specimens.

9. How the Ground Truth for the Training Set Was Established:

As there's no explicitly defined "training set" in the AI sense for this type of IVD device, the method for establishing its ground truth isn't applicable. The performance is based on the chemical reactions of the strips and the optical reading capabilities of the analyzer, which would have been rigorously developed and validated against known concentrations of analytes and reference methods during the product development phase.

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